Label: Information for the Patient

Lacosamida Tarbis Farma 10 mg/ml Solution for Infusion EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

What is Lacosamida Tarbis Farma

Lacosamida Tarbis Farma contains lacosamida, which belongs to a group of medicines called “antiepileptic medicines”.These medicines are used to treat epilepsy.

• You have been prescribed this medicine to reduce the number of seizures you experience.

What is Lacosamida Tarbis Farma used for

• Lacosamida is used:
• • alone and in combination with other antiepileptic medicines in adults, adolescents, and children aged 2 years and older to treat a certain type of epilepsy characterized by the occurrence of partial onset seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of the brain. However, they may then spread to larger areas on both sides of the brain;
  • in combination with other antiepileptic medicines in adults, adolescents, and children aged 4 years and older to treat primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).

Do not use Lacosamida Tarbis Farma

• if you are allergic to lacosamida or any of the other ingredients of this medication (listed in section 6). If you are unsure if you are allergic, consult your doctor.
• if you have a certain type of heart rhythm problem called second- or third-degree AV block.

Do not use lacosamida if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use this medication.

Warnings and precautions

Consult your doctor before starting to use lacosamida if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medications such as lacosamida have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
• you have a heart problem that affects your heart rhythm and your pulse is often abnormally slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter)
• you have a serious heart condition such as heart failure or have had a heart attack.
• you often feel dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidents or falls. This means you should be careful until you are used to the effects of this medication.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before starting to use lacosamida.

If you are taking lacosamida, consult your doctor if you experience a new type of seizure or worsening of existing seizures.

If you are taking lacosamida and experience symptoms of abnormal heart rhythm (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, or fainting), consult your doctor immediately (see section 4).

Children

Lacosamida is not recommended for children under 2 years with epilepsy characterized by the onset of partial seizures and is not recommended for children under 4 years with primary generalized tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children in this age group.

Other medications and Lacosamida Tarbis Farma

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamida may also affect the heart:

• medications to treat heart problems;
• medications that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, and pregabalin;
• medications used to treat certain types of arrhythmia or heart failure.

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before starting to use lacosamida.

Also inform your doctor or pharmacist if you are taking any of the following medications, as they may increase or decrease the effect of lacosamida in your body:

• antifungal medications such as fluconazole, itraconazole, and ketoconazole;
• an HIV medication such as ritonavir
• antibacterial medications such as clarithromycin and rifampicin;
• a medicinal herb used to treat mild anxiety and depression called St. John's Wort

If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before starting to use lacosamida.

Use of Lacosamida Tarbis Farma with alcohol

As a precaution, do not use lacosamida with alcohol.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraceptives with their doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Lacosamida is not recommended during pregnancy, as its effects on pregnancy and the fetus are not known.

It is not recommended to breastfeed while taking lacosamida, as lacosamida passes into breast milk.

Seek advice immediately from your doctor if you are pregnant or plan to become pregnant. They will help you decide if you should take lacosamida or not.

Do not stop treatment without speaking with your doctor, as this may increase seizures (crises). A worsening of your condition may also harm the fetus.

Driving and operating machinery

You should not drive, cycle, or use machines until you know if this medication affects you. The reason is that lacosamida may cause dizziness or blurred vision.

Lacosamida Tarbis Farma contains sodium

This medication contains 59.8 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use of Lacosamida Tarbis Farma

• The treatment with lacosamida can be initiated:
• • by taking the medication orally or
  • administered in the form of intravenous infusion (also known as IV infusion) with which the doctor or nurse administers the medication through a vein.The administration lasts from 15 to 60 minutes.
• The IV infusion is usually used for a short period of time, when the medication cannot be taken orally.
• Your doctor will decide for how many days you will be administered infusions. There is experience with the administration of lacosamida infusions twice a day for up to 5 days. For long-term treatment, lacosamida tablets and syrup are available.

When changing the infusion to start taking the medication orally or vice versa, the total amount you will take per day and the frequency of taking will remain the same.

• Use lacosamida twice a day (with an interval of approximately 12 hours).
• Try to use it at about the same time each day.

What dose to use

The following are the normal recommended doses of lacosamida for different age groups and weights. Your doctor may prescribe a different dose if you have kidney or liver problems.

Adolescents and children weighing 50 kg or more and adults

When using lacosamida alone:

• The usual starting dose is 50 mg twice a day.
• Treatment with lacosamida can also begin with a dose of 100 mg of lacosamida twice a day.
• Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When using lacosamida with other antiepileptic medications:

The usual starting dose is 50 mg twice a day.

Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 200 mg twice a day.

If you weigh 50 kg or more, your doctor may decide to start treatment with a single "loading" dose of 200 mg. You will then start taking your regular maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

• For the treatment of partial onset seizures:Lacosamida is not recommended for children under 2 years of age.
• For the treatment of primary generalized tonic-clonic seizures:Lacosamida is not recommended for children under 4 years of age.

When using lacosamida alone

• Your doctor will determine the dose of lacosamida based on your body weight.
• The usual starting dose is 1 mg (0.1 ml) per kilogram (kg), twice a day.
• Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight each week, until you reach the maintenance dose.
• The following are the dosing tables with the maximum recommended dose.
• These doses are merely informative. Your doctor will calculate the correct dose for you.

Ato be taken twice a day,for children aged 2 years or older whoweigh between 10 kg and less than 40 kg

To be taken twice a day, for adolescents and childrenwho weigh between 40 kg and less than 50 kg:

When using lacosamida with other antiepileptic medications

• Your doctor will determine the dose of lacosamida based on your body weight.
• For children and adolescents who weigh between 10 kg and less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
• Your doctor may increase the dose you take twice a day each week by 1 mg (0.1 ml) per kg of body weight, until you reach the maintenance dose.
• The following are the dosing tables with the maximum recommended dose.
• These doses are merely informative. Your doctor will calculate the correct dose for you.

To be taken twice a day,for children aged 2 years or olderwho weigh between 10 kg and less than 20 kg

To be taken twice a day, for adolescents and childrenwho weigh between 20 kg and less than 30 kg:

To be taken twice a day,for adolescents and childrenwho weigh between 30 kg and less than 50 kg

If you interrupt treatment with Lacosamida Tarbis Farma

If your doctor decides to stop your treatment with lacosamida, they will gradually reduce your dose. This is to prevent your epilepsy from returning or getting worse.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects in the nervous system, such as dizziness, may be more pronounced after a single "loading" dose.

Inform your doctor or pharmacist if you experience any of the following side effects:

Very common:may affect more than 1 in 10 patients

• Headache;
• Feeling dizzy or nauseous;
• Diplopia (double vision).

Common:may affect up to 1 in 10 patients

• Myoclonic seizures (brief muscle or muscle group spasms);
• Difficulty coordinating movements or walking;
• Balance problems, agitation (tremor), paresthesia (tingling), or muscle spasms, easy to fall and bruise;
• Memory problems, difficulty thinking or finding words, confusion;
• Uncontrolled rapid eye movements (nystagmus), blurred vision;
• Sensation of dizziness (vertigo), feeling drunk;
• Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
• Decreased sensitivity, difficulty articulating words, attention disorder;
• Ringing in the ears like buzzing or hissing;
• Irritability, difficulty sleeping, depression;
• Drowsiness, fatigue, or weakness (asthenia);
• Itching, rash.

Uncommon:may affect up to 1 in 100 patients

• Decreased heart rate, palpitations, irregular pulse, or other changes in heart electrical activity (conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not real;
• Allergic reaction to the medication, hives;
• Blood tests may show liver function abnormalities, liver damage;
• Thoughts of self-harm or suicide or attempted suicide: inform your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts and/or loss of sense of reality;
• Severe allergic reactions, which cause swelling of the face, throat, hands, feet, ankles, or lower legs;
• Loss of consciousness;
• Abnormal involuntary movements (dyskinesia).

Frequency not known:cannot be estimated from available data

• Abnormally fast heart rate (ventricular tachyarrhythmia);
• Sore throat, elevated temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);
• Severe skin reaction, which may include elevated temperature and other flu-like symptoms, widespread rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
• Generalized blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis);
• Seizures.

Other side effects of intravenous administration

Local adverse reactions may occur.

Common:may affect up to 1 in 10 patients

• Pain or discomfort at the injection site or irritation.

Uncommon:may affect up to 1 in 100 patients

• Redness at the injection site.

Other side effects in children

Additional side effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting normally (abnormal behavior), and lethargy. Drowsiness is a very common side effect in children and may affect more than 1 in 10 children.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and in the vial. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Each vial of Lacosamida Tarbis Farma infusion solution must be used only once (single use). Unused solution must be discarded.

Only clear solutions, free of particles and without color change should be used.

Medications should not be thrown down the drain or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lacosamida Tarbis Farma

The active ingredient is lacosamida.

1 ml of Lacosamida Tarbis Farma infusion solution contains 10 mg of lacosamida.

1 vial contains 20 ml of infusion solution, equivalent to 200 mg of lacosamida.

The other components are:

sodium chloride, hydrochloric acid 0.85% v/v, and water for injection preparations.

Appearance of the product and contents of the package

Lacosamida Tarbis Farma 10 mg/ml infusion solution is a transparent and colorless solution.

Lacosamida Tarbis Farma infusion solution is available in packages of 1 vial and 5 vials.

Each vial contains 20 ml.

Only some package sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Lacosamid Amarox 10 mg/ml Infusionslösung

Spain: Lacosamida Tarbis Farma 10 mg/ml solution for perfusion EFG

Netherlands: Lacosamide Amarox 10 mg/ml, oplossing voor infusie

Revision date of this leaflet: October 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended only for doctors or healthcare professionals:

Each vial of Lacosamida Tarbis Farma infusion solution should be used only once (single use). Unused solution should be discarded (see section 3).

Lacosamida Tarbis Farma infusion solution can be administered without additional dilution, or it can be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), or Ringer lactate solution.

From a microbiological point of view, the medicine should be used immediately. If not used immediately, storage times in use and previous conditions are the responsibility of the user and should not exceed 24 hours at a temperature of between 2 and 8 °C, unless the dilution has taken place in validated and controlled conditions.

Chemical and physical stability in use has been demonstrated for 24 hours at temperatures up to 25 °C for medicines mixed with these diluents and stored in glass or PVC bags.